Data from two preclinical studies of investigational pulsed field ablation (PFA) products were selected for oral presentations and highlight the company’s commitment to developing a comprehensive PFA technology

New web-based resource provides information for physicians to better understand PFA data generated by Biosense Webster

Irvine, CA – May 19, 2023 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,¹ announced that data from two company-sponsored preclinical studies evaluating THERMOCOOL SMARTTOUCH™ SF Dual Energy Catheter and the TRUPULSE™ Generator will be presented at Heart Rhythm 2023, the Heart Rhythm Society’s annual meeting, taking place in New Orleans, Louisiana from May 19-21. Pulsed field ablation (PFA) represents a new chapter in treating atrial fibrillation (AFib), utilizing a controlled electric field – instead of thermal energy – to ablate and treat cardiac tissue.

“As a company that has been dedicated to excellence and innovation in cardiac ablation for nearly three decades, Biosense Webster is excited about the potential of PFA in increasing access to treatment for patients around the world,” said Celine Martin, Company Group Chairman, Cardiovascular & Specialty Solutions Group, Johnson & Johnson MedTech. “As we continue to investigate and develop PFA technologies – complementary to our world-class radio frequency ablation portfolio – we are generating the data that physicians need to appropriately and effectively utilize this new technology.”

A new webpage is now available to share with physicians that includes information about specific preclinical and clinical data from Biosense Webster’s individual PFA studies. It contains information on ongoing PFA research efforts, including clinical trials, publications, and educational resources. As more evidence becomes available, it will be a valuable source to keep health care providers appraised of the latest developments in the company’s effort to develop PFA technologies.

AFib is the most common type of cardiac arrhythmia affecting an estimated 37.5 million people globally.¹ By 2030, the number of people with AFib is projected to increase by up to 70 percent.² Given those projections, physicians are looking for innovative ways to improve the safety, efficacy and efficiency of procedures and deliver better outcomes for their patients. PFA has the potential to widen accessibility to cardiac ablation through more safe and efficient procedures.

PFA represents a significant advancement in the field of cardiac ablation,” said Luigi Di Biase, MD, PhD, FACC, FHRS, Section Head of Electrophysiology, Director of Arrhythmia Services, Montefiore-Einstein Center for Heart & Vascular Care, and Professor of Medicine (Cardiology), Albert Einstein College of Medicine, and lead investigator in one of the PFA preclinical studies.² “These data from preclinical studies help advance our understanding of PFA and how we can harness the full potential of this new technology.”

The two preclinical abstracts include: 

Effects of Electrode Contact Force on Lesion Size Produced by Pulsed Field Ablation. Oral Presentation Session AB-452672-1 / Room 218, May 21, 8:00 a.m. to 8:12 a.m. CT by Dr. Hiroshi Nakagawa

This study aimed to determine the relationship between contact force and lesion quality with PFA ablation using Biosense Webster’s investigational THERMOCOOL SMARTTOUCH™ SF Dual Energy Catheter in a swine beating heart model. At constant pulsed electric field dose applications, lesion depth increased significantly with increasing contact force (P < 0.01), suggesting that electrode-tissue contact is required for effective lesion formation during PFA.

Point-by-Point Pulsed Field Ablation Using a Multimodality Generator: Comparison With Radiofrequency Ablation in Remapped Chronic Swine Hearts. Oral Presentation Session AB-452672-4 / Room 218, May 21, 8:36 a.m. to 8:48 a.m. CT by Dr. Luigi Di Biase

This preclinical study compared lesion durability and collateral damage between unipolar/biphasic PFA and radiofrequency energy delivered in a point-by-point fashion. PFA showed durable pulmonary vein isolation lesions acutely and at remapping without any sign of collateral damage after 28 days. Compared to radiofrequency lesions, histology evaluations showed that the PFA lesions demonstrated scar tissue without signs of necrosis or inflammation. 

Visit Biosense Webster’s Scientific Session Guide for the full list of Biosense Webster data being presented at Heart Rhythm 2023.

About Biosense Webster
Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at  biosensewebster.com and connect on LinkedIn and Twitter.

About Johnson & Johnson MedTechⁱ
At Johnson & Johnson MedTech,ⁱ we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

Caution: US law restricts this device to sale by or on the order of a physician.

References

1. Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021;16(2):217-221.
2. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220.

1. Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
2. Montefiore Medical Center entered in the contractual agreement with BWI to conduct the study. Dr. Luigi Di Biase was not compensated for his authorship contributions.

© Biosense Webster, Inc. 2023 247314-230503